Τίτλος:
Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
BACKGROUND: In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. PATIENTS AND METHODS: The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. RESULTS: The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. CONCLUSIONS: In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile. Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.
Συγγραφείς:
Rugo, H.S.
O'Shaughnessy, J.
Boyle, F.
Toi, M.
Broom, R.
Blancas, I.
Gumus, M.
Yamashita, T.
Im, Y.-H.
Rastogi, P.
Zagouri, F.
Song, C.
Campone, M.
San Antonio, B.
Shahir, A.
Hulstijn, M.
Brown, J.
Zimmermann, A.
Wei, R.
Johnston, S.R.D.
Reinisch, M.
Tolaney, S.M.
monarchE Committee Members
Περιοδικό:
Annals of oncology: official journal of the European Society for Medical Oncology
Λέξεις-κλειδιά:
abemaciclib; aminopyridine derivative; antineoplastic agent; benzimidazole derivative; epidermal growth factor receptor 2, breast tumor; diarrhea; female; human; metabolism; patient-reported outcome; quality of life; tumor recurrence, Aminopyridines; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; Breast Neoplasms; Diarrhea; Female; Humans; Neoplasm Recurrence, Local; Patient Reported Outcome Measures; Quality of Life; Receptor, ErbB-2
DOI:
10.1016/j.annonc.2022.03.006
